Medtronic 5867-3M Technical Manual

5867-3M

Lead end cap kit

Technical Manual

Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician.

The following list includes trademarks or registered trademarks of
Medtronic in the United States and possibly in other countries. All other
trademarks are the property of their respective owners.

Medtronic

Description/intended use

The 5867-3M Lead end cap kit consists of three types
of lead end caps—one intended to seal off leads with
Medtronic unipolar connectors 5 mm (0.2 in) or
bipolar connectors 5 mm (0.2 in) bifurcated, one
intended to seal off leads with unipolar connectors
(IS-11 UNI) or bipolar connectors (IS-1 BI), and one
intended to seal off leads with Medtronic bipolar
connectors (3.2 mm low profile) or severed lead
bodies with an outer diameter of 1.5 to 2.8 mm (4.6 to

8.4 Fr).

All three types of lead end caps are made of silicone
rubber.

The Model 5867-3M is intended for single use only.

Package contents

Dispose of all single-use accessories according to
local environmental requirements. Each package
contains the following items:

• 2 unipolar 5 mm (0.2 in) lead end caps

• 1 IS-1 UNI/BI lead end cap

• 1 bipolar 3.2 mm (0.13 in) low profile lead end cap

• Product documentation

Contraindications

To date, there are no known contraindications to the
use of the 5867-3M Lead end cap kit.

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IS-1 refers to an International Connector Standard (ISO
5841-3) whereby devices and leads so designated are
assured of a basic mechanical fit.

3

Warnings and precautions

Note: Medical procedure warnings and precautions

that pertain to the Medtronic implanted system are
provided in the manual that is packaged with the
device or on the Medtronic Manual Library website
(www.Medtronic.com/manuals).

Review the lead documentation – Since the lead
end cap is a functional extension of the lead, it is
recommended that the lead documentation be
reviewed for all appropriate warnings, complications,
precautions, and instructions.

Line-powered and battery-powered equipment –

An implanted lead forms a direct current path to the
myocardium. During lead implant and testing, use
only battery-powered equipment or line-powered
equipment specifically designed for this purpose to
protect against fibrillation that may be caused by
alternating currents. Line-powered equipment used
in the vicinity of the patient must be properly
grounded. Lead connector pins must be insulated
from any leakage currents that may arise from
line-powered equipment.

External defibrillation equipment – Keep external
defibrillation equipment nearby for immediate use
during the implant procedure and whenever
arrhythmias are possible or intentionally induced.

Handling the lead end caps – Lead insulators
attract small particles such as lint and dust; therefore,
protect the lead end cap(s) from materials shedding
these substances.

Sterilization – Medtronic has sterilized the package
contents with ethylene oxide before shipment. This
device is for single use only and is not intended to be
resterilized.

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Inspecting the sterile package – Inspect the sterile
package with care before opening it.

• Contact a Medtronic representative if the seal or
package is damaged.

• Do not use the product after its expiration date.

Instructions for use

Using the unipolar 5 mm (0.2 in)/ bipolar 5 mm
(0.2 in) bifurcated lead end caps or the unipolar
(IS-1 UNI) / bipolar (IS-1BI) lead end cap

1. Identify whether the lead connector to be
capped is a Medtronic unipolar 5 mm (0.2 in)
connector, a Medtronic bipolar 5 mm (0.2 in)
bifurcated connector, a unipolar connector (IS-1
UNI), or a bipolar connector (IS-1 BI).

Use one unipolar 5 mm (0.2 in) lead end cap for
the unipolar connector 5 mm (0.2 in) and two
unipolar 5 mm (0.2 in) lead end caps for the
bipolar connector 5 mm (0.2 in) bifurcated. See
Figure 1. Use the (IS-1 UNI/BI) lead end cap for
either the unipolar connector (IS-1 UNI) or the
bipolar connector (IS-1 BI). See Figure 2.

Figure 1. Unipolar 5 mm (0.2 in)/Bipolar 5 mm (0.2 in) bifurcated lead end cap

Figure 2. Unipolar (IS-1 UNI)/Bipolar (IS-1 BI) lead end cap

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2. For the 5 mm (0.2 in) connector application,
insert the lead end cap on the lead connector so
that the three sealing rings on the 5 mm (0.2 in)
connector are fully engaged inside the end cap.
For the IS-1 UNI/BI connector application, insert
the lead end cap on the lead connector so that
the outer sealing rings on IS-1 connector are
fully engaged inside the end cap. Sterile water
may be used to facilitate this application. No
adhesives are necessary.

3. Place and tie a nonabsorbable, synthetic
ligature in the single groove of the lead end cap.

4. The lead end cap can be removed at a later date
without damage to the lead connector by
removing the suture.

Using the bipolar 3.2 mm (0.13 in) low
profile/severed lead end cap

1. Identify whether the lead connector to be
capped is a Medtronic bipolar connector 3.2 mm
(0.13 in) low profile or a severed lead body. Use
the bipolar 3.2 mm (0.13 in) low profile lead end
cap for lead connectors with a bipolar connector

3.2 mm (0.13 in) low profile and severed lead
bodies with an outer body diameter between

1.5 mm-2.8 mm (4.6-8.4 Fr). See Figure 3.

2. For the 3.2 mm (0.13 in) connector application,
insert the lead end cap on the bipolar connector

3.2 mm (0.13 in) low profile so that the sealing
rings on the end cap fully engage the lead
connector. For a severed lead body application
with a diameter of 2 mm (6 Fr) or less, insert the
lead body through three of the ligature sites on
the end cap. For a severed body application with
a diameter greater than 2 mm (6 Fr), insert the
lead body through the first two ligature sites on

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the end cap. Sterile water may be used to
facilitate this application. No adhesives are
necessary.

3. Place and tie two nonabsorbable, synthetic
ligatures in the first two grooves of the end cap
for bipolar 3.2 mm (0.13 in) low profile
application and for severed lead bodies with a
diameter greater than 2 mm (6 Fr). Place and tie
three nonabsorbable, synthetic ligatures in
three grooves of the end cap for severed lead
bodies with a diameter of 2 mm (6 Fr) or less.

Figure 3. Bipolar 3.2 mm (0.13 in) low profile/severed body lead end cap

4. The lead end cap can be removed at a later date
without damage to the lead connector by
removing the sutures.

Special notice

Medtronic Lead End Caps are used with leads, which
are implanted in the extremely hostile environment of
the human body. Leads or lead end caps may fail to
function for a variety of causes, including, but not
limited to: medical complications, body rejection
phenomena, allergic reaction, fibrotic tissue, or
failure of leads by breakage or by breach of their
insulation covering. In addition, despite the exercise
of all due care in design, component selection,
manufacture, and testing prior to sale, leads or lead
end caps may be easily damaged before, during, or
after insertion by improper handling or other
intervening acts. Consequently, for leads used with
lead end caps, no representation or warranty is made

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that failure or cessation of function will not occur or
that the body will not react adversely to the
implantation of leads or that medical complications
(including perforation of the heart) will not follow.

Medtronic disclaimer of warranty

For complete disclaimer of warranty information, see
the accompanying disclaimer of warranty document.

Service

Medtronic employs highly trained representatives
and engineers located throughout the world to serve
you and, upon request, to provide training to qualified
hospital personnel in the use of Medtronic products.
Medtronic also maintains a professional staff to
provide technical consultation to product users. For
more information, contact your local Medtronic
representative, or call or write Medtronic at the
appropriate telephone number or address listed on
the back cover.

CE mark of conformity

The following CE mark of conformity applies to the
Model 5867-3M lead end cap kit.

1994

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Explanation of symbols

Table 1. Explanation of symbols on package

labeling
Refer to the package labels to see which symbols

apply to this product.

Conformité Européenne (European
Conformity). This symbol means
that the device fully complies with
applicable European Union acts.

For U.S. audiences only

Authorized representative in the
European community

Date of manufacture

Manufacturer

Use by

Lot number

Reorder number

Serial number

Sterilized using ethylene oxide

Do not reuse

Do not use if package is damaged

9

Table 1. Explanation of symbols on package
labeling (continued)

Upper limit of temperature

Open here

Consult instructions for use at this
website

Package contents

Product documentation

For use with Medtronic lead

5 mm lead end cap

3.2 mm lead end cap

IS-1 lead end cap

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Medtronic, Inc.

*M971362A001*

710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
[phone]

Europe/Middle East/Africa

Medtronic International
Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
[phone]

Australia

Medtronic Australasia Pty Ltd
5 Alma Road
Macquarie Park, NSW 2113
Australia
1800 668 670

Canada

Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
[phone]

Technical manuals

www.medtronic.com/manuals

© 2017 Medtronic
M971362A001 A
2017-08-02